The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Implantation of drug eluting stent
Tokai University Hospital
Isehara, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, Japan
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
Time frame: 9 months
Device Success rate
Device success is defined as successfully placement of the investigational stent at the target lesion, and attainment of less than 50% residual stenosis at the end of stenting.
Time frame: Immediate post-procedure
Procedure success rate
Procedure success is defined as attainment of less than 50% residual stenosis at the end of stenting and no major adverse cardiac events (death (excluding cases obviously caused by other than coronary ischemia), myocardial infarction, target lesion revascularization (TLR)) during hospitalization.
Time frame: At the time of hospital discharge, expected 1or 2 days after of procedure
Target Lesion Failure (TLF)
Time frame: 9 Months
Target Vessel Failure (TVF)
Time frame: 9 Months
Stent thrombosis
Time frame: 9 Months
Patient Oriented Composite End point (POCE)
POCE: All cause death, all myocardial infarction, or all revascularization with ischemia
Time frame: 9 Months
In-stent and in-segment %diameter stenosis (%DS) as measured by QCA
Time frame: 9 Months
In-stent and in-segment %Angiographic Binary Restenosis (%ABR)
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Mitsui Memorial Hospital
Chiyoda City, Tokyo, Japan
Teikyo University Hospital
tabashi City, Tokyo, Japan
Time frame: 9 Months
Neointima volume as measured by OCT/OFDI
Time frame: 9 Months
%Volume obstruction as measured by OCT/OFDI
Time frame: 9 Months
%Incomplete stent apposition (%ISA) as measured by OCT/OFDI
Time frame: 9 Months
%Covered strut as measured by OCT/OFDI
Time frame: 9 Months